MAUDE Adverse Event Report: SEPTODONT INC. HENRY SCHEIN MULTI-USE DISPENSER

Catalog Number FPSCHEIN-175

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation ongoing.

Event Description

(b)(4).Initial information received by dealer on 19-dec-2016 and additional information was received by dealer on 28-dec-2016.Both initial and additional information were sent to (b)(4) on 28-dec-2016.Case 1 of 2.Linked with local reference # (b)(4)(same reporting dental clinic, same device, same reported concern).The 2 cases concern 2 different identified patients: a (b)(6) female patient and a (b)(6) male patient.However it could not be determined which of these two patients was concerned by the following reported information.On (b)(6) 2016, while dental clinic staff (b)(6) was placing the resin on the back tooth.The suspect dispenser henry schein multi-use dispenser (lot # not available) snaps and makes a very loud noise.Nobody was hurt or injured but the potential for the car pule to be swallowed was very high.No lot # available.Additional narrative received on 06-feb-2017: a unidose resin capsule was placed in the suspect multiuse dispenser and the dentist was squeezing the resin into the mouth as usual.The suspect device "popped" the very moment the device handle was squeezed.When asked which part of the suspect multiuse dispenser was broken, it is indicated by the complainant it was at "the silver thing at the tip of the gun [suspect multiuse dispenser] when you put the unidose resin", "the hard outer shell broke" and it made such a loud noise it seemed like an actual gun was fired.According to the complainant, the reported breakage had already happened to 3 different multiuse dispensers.Additional information received on 07-feb-2017: it was confirmed by the complainant that the previous two multiuse dispensers "broke in the exact same way.While dispersing the resin capsule in the mouth.We are very luck none of the pieces went down the patient at mouth".On 08-feb-2017, it was determined by (b)(4) that the reported malfunction failed to perform as intended and that the suspect device is likely to cause or contribute to a serious injury if the malfunction were to recur.On 21-feb-2017, (b)(4) contacted supplier of the a "other number" on the returned device sample was identified as "i6802", which permit septodont to determine device manufacturing date as 09-jul-2014.Call log was received from qa on current investigation status.Causality assessment on 10-mar-2017 by al on initial information received on 02-feb-2017, and additional information received on 06-feb-2017, 07-feb-2017, 08-feb-2017 and 21-feb-2017: seriousness: serious (determined by (b)(4) that the reported malfunction failed to perform as intended and that the suspect device is likely to cause or contribute to a serious injury if the malfunction were to recur.) listedness/expectedness: device breakage: unlisted eu; unexpected us/ca.No adverse event: listed eu; expected us/ca.Causality: latency - unknown; recognized association - no; analysis - the reporter had 2 similar events of device breakage in 2 identified patients.The device was returned to quality department only for one of them.Breakage of the device could be due to anomaly of the material, however call log received from qa on current investigation status stated that the returned dispenser appeared to be dropped, and that it was heavily used due to buildup on the pin.Therefore, without other information, since no adverse event was reported and considering state of use of the device, the causality between the dispenser and device breakage was assessed as unlikely.The event no adverse event was not assessable; dechallenge - na; rechallenge - na.Concluded causality who: unlikely for device breakage, not assessable for no adverse event.

• Brand Name: HENRY SCHEIN MULTI-USE DISPENSER
• Type of Device: MULTI-USE DISPENSER
• Manufacturer (Section D): SEPTODONT INC.; 418s taylor ave.; louisville CO 80027
• Manufacturer Contact: lawrence kass ; 416 south taylor ave.; louisville, CO 80027 ; 3036657535
• MDR Report Key: 6395374
• MDR Text Key: 70058518
• Report Number: 0001721729-2017-00001
• Device Sequence Number: 1
• Product Code: EIY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: FPSCHEIN-175
• Device Lot Number: I6802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR